Department of Surgery, University of Michigan, Ann Arbor.
Department of Urology, University of Michigan, Ann Arbor.
JAMA Surg. 2018 Dec 1;153(12):1111-1119. doi: 10.1001/jamasurg.2018.2651.
In 2014, the US Drug Enforcement Administration moved hydrocodone-containing analgesics from schedule III to the more restrictive schedule II to limit prescribing and decrease nonmedical opioid use. The association of this policy change with postoperative prescribing is not well understood.
To examine the hypothesis that the amount of opioids prescribed following surgery is associated with the rescheduling of hydrocodone.
DESIGN, SETTING, AND PARTICIPANTS: An interrupted time series analysis of outpatient opioid prescriptions was conducted to examine the trends in the amount of postoperative opioids filled before and after the schedule change. Opioid prescriptions filled between January 2012 and October 2015 were analyzed using insurance claims data from the Michigan Value Collaborative, which includes data from 75 hospitals across Michigan. A total of 21 955 adult inpatients 18 to 64 years of age who underwent 1 of 19 common elective surgical procedures and filled an opioid prescription within 14 days of discharge to home were eligible for inclusion.
The primary outcome was the trends in the mean amount of opioids filled in oral morphine equivalents (OMEs) for the initial postoperative prescriptions before and after the schedule change date of October 6, 2014, compared using interrupted time series and multivariable regression analyses. Secondary outcomes included the total amount of opioids filled and the refill rate for the 30-day postoperative period. Subgroup analyses were performed by hydrocodone prescriptions, nonhydrocodone prescriptions, surgical procedure, and prior opioid use.
Data from 21 955 patients undergoing surgical procedures across 75 hospitals and 5120 prescribers were analyzed. Cohorts before and after the schedule change were equivalent with respect to sex (10 197 of 15 791 [64.6%] vs 3966 of 6169 [64.3%] female; P = .69) and mean (SE) age (47.9 [11.2] vs 47.7 [11.3] years; P = .19). After the schedule change, the mean OMEs filled in the initial opioid prescription increased by approximately 35 OMEs (β = 35.1 [13.2]; P < .01), equivalent to 7 tablets of hydrocodone (5 mg). There were no significant differences in the total OMEs filled during the 30-day postoperative period before and after the schedule change (β = 18.3 [30.5]; P = .55), but there was a significant decrease in the refill rate (β = -5.2% [1.3%]; P < .001).
Changing hydrocodone from schedule III to schedule II was associated with an increase in the amount of opioids filled in the initial prescription following surgery. Opioid-related policies require close follow-up to identify and address early unintended effects given the multitude of competing factors that influence health care professional prescribing behaviors.
2014 年，美国缉毒局将含羟考酮的镇痛药从附表 III 移至更严格的附表 II，以限制处方数量并减少非医疗用途的阿片类药物使用。人们对这一政策变化与术后处方之间的关联还不太了解。
检验以下假设，即手术后开的阿片类药物数量与羟考酮的重新分类有关。
设计、地点和参与者：采用门诊阿片类药物处方的中断时间序列分析，以检查手术前后术后阿片类药物用量的趋势。使用密歇根价值合作组织的保险索赔数据对 2012 年 1 月至 2015 年 10 月期间的阿片类药物处方进行分析，该组织的数据来自密歇根州的 75 家医院。共有 21955 名 18 至 64 岁的成年住院患者符合入选条件，他们接受了 19 种常见的选择性手术之一，并在出院后 14 天内开出了阿片类药物处方。
主要结局是比较 2014 年 10 月 6 日（时间表变更日期）前后初始术后处方中口服吗啡当量（OME）的阿片类药物用量趋势，使用中断时间序列和多变量回归分析。次要结局包括术后 30 天内的总阿片类药物用量和再配药率。进行了羟考酮处方、非羟考酮处方、手术程序和先前阿片类药物使用的亚组分析。
对来自 75 家医院和 5120 名处方医生的 21955 名接受手术的患者的数据进行了分析。时间表变更前后的队列在性别方面是等效的（15791 名中有 10197 名[64.6%]为女性；6169 名中有 3966 名[64.3%]为女性；P = .69），平均（SE）年龄（47.9[11.2] vs 47.7[11.3]岁；P = .19）。时间表变更后，初始阿片类药物处方中 OME 的平均用量增加了约 35 OME（β = 35.1[13.2]；P < .01），相当于 7 片羟考酮（5 毫克）。在时间表变更前后的 30 天术后期间，总 OME 用量无显著差异（β = 18.3[30.5]；P = .55），但再配药率显著下降（β = -5.2%[1.3%]；P < .001）。
将羟考酮从附表 III 改为附表 II 与手术后初始处方中阿片类药物用量的增加有关。鉴于影响医疗保健专业人员处方行为的众多竞争因素，阿片类药物相关政策需要密切跟踪，以识别和解决早期的意外影响。
